What are the responsibilities and job description for the SENIOR QUALITY ASSOCIATE- RISK MANAGEMENT position at Bridgeway Partners, Inc.?
Senior Quality Associate Biotech / Pharmaceutical Risk Management Focus
Are you ready to make a real impact in the world of biotechnology and pharmaceutical manufacturing? We are seeking an experienced Senior Quality Associate with a strong background in Risk Management to join our team in the Midwest . This role is key to ensuring the highest standards of product quality and regulatory compliance, with a focus on ICH Q9 and other relevant guidelines.
About Us :
The company is an innovative leader in the biotech and pharmaceutical industry, committed to advancing scientific breakthroughs that improve lives globally. Youll work alongside a dedicated team to support the development of life-saving therapies, applying cutting-edge technologies to meet todays most complex challenges.
Key Responsibilities :
- Lead Risk Management activities, ensuring compliance with ICH Q9 and supporting product quality across the entire lifecycle.
- Collaborate with cross-functional teams including Quality Assurance (QA), Operations, and Regulatory Affairs to develop, implement, and maintain risk management processes.
- Conduct and oversee Failure Mode Effects Analysis (FMEA) , root cause analysis, and other risk assessment tools to mitigate quality risks in manufacturing and development processes.
- Provide real-time oversight and guidance on the manufacturing floor, ensuring that Good Manufacturing Practices (GMP) are consistently followed.
- Review and approve quality-related documentation including batch records , risk assessments, and quality investigations.
- Develop and monitor process capability metrics, utilizing statistical tools to drive continuous improvement.
Qualifications :
Relocation :
This role is based in the Midwest , and relocation assistance is available. Were seeking a dynamic individual eager to take on a key role and willing to relocate for 2-3 years to the Midwest.